Development of a Tai Chi Program to Overcome Barriers to Cardiac Rehabilitation

开发太极拳项目以克服心脏康复障碍

• 批准号: 8581712
• 负责人: Elena Salmoirago-Blotcher
• 金额: $ 7.89万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8581712
• 关键词: Acute; Address; Adherence; Adult; Aerobic; Aerobic Exercise; Age; American Heart Association; Angioplasty; Anxiety; Attention; Body Weight; Cardiac; Cardiology; Cardiovascular system; Characteristics; Communities; Control Groups; Coronary; Coronary heart disease; Delphi Technique; Development; Dose; Educational process of instructing; Elderly; Enrollment; Equipment; Event; Exercise; Exercise Physiology; Exercise Tolerance; Female; Focus Groups; Frequencies; Fright; Funding Mechanisms; Future; Gender; Goals; Heart; Heart failure; Home environment; Individual; Intervention; Life; Life Style; Light; Lipids; Measurement; Measures; Mental Depression; Mind-Body Intervention; Moods; Myocardial Infarction; Operative Surgical Procedures; Outcome; Overweight; Patients; Phase; Physical activity; Population; Population Study; Preparation; Prevention program; Procedures; Program Development; Protocols documentation; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Recommendation; Rehabilitation therapy; Relative (related person); Risk Factors; Safety; Secondary Prevention; Self Efficacy; Serum; Sleep; Social support; Surveys; Tai Ji; Techniques; Testing; Text; Time; Training; Transportation; Treatment Protocols; Underserved Population; Validation; Weight Gain; Work; arm; base; cost; design; efficacy testing; fitness; high risk; improved; innovation; mindfulness; mortality; operation; outcome forecast; programs; public health relevance; sedentary; social; therapy design; therapy development

DESCRIPTION (provided by applicant): Cardiac rehabilitation programs (CRP) reduce overall and cardiovascular mortality in patients recovering from acute coronary events or revascularization procedures. Modifiable coronary risk factors such as physical inactivity, overweight and high serum lipid levels also improve after CRPs. However, only 30% of patients currently enroll in CRPs and attrition may reach 60%. Barriers include older age, female gender, fear or dislike for the type of exercise training proposed in CRPs, lack of social support, depression and distance from CRP center. Clearly, there is a need to develop programs tailored to the characteristics and needs of those who do not attend presently available programs. Tai Chi, a mind-body intervention based on light/moderate aerobic exercise accompanied by meditative components, has improved aerobic capacity in older sedentary adults as well as exercise self-efficacy, quality of life and mood in patients with heart failure. Tai Chi can be practiced safely by elderly and deconditioned individuals; it does not require any particular equipment and it may be performed at any time and place. Since Tai Chi is usually taught in groups, and is safe even in high-risk patients, it has been successfully offered in community centers thus overcoming transportation barriers and limiting costs. All these characteristics indicate that Tai Chi may overcome multiple barriers to traditional CRP and could be proposed as an alternative intervention for patient unwilling to attend traditional CRPs. Our long-term goal is conduct a phase III randomized clinical trial (RCT) to determine the efficacy of Tai Chi in improving overall physical activity in patients with recent coronary events or procedures that are unable or unwilling to attend traditional CRPs. The objectives of this treatment development study are to define the content, optimal dose, feasibility and safety of a Tai Chi intervention in this new population and to optimize the design of the future RCT. Specifically, (aim 1) we will use a modified Delphi technique to develop a Tai Chi intervention tailored to the specific rehabilitative needs of patients with recent coronary events or procedures that are unable or unwilling to attend traditional CRPs. Next, (aim 2) we will define the appropriate dose of the intervention by comparing the feasibility, acceptability and safety of two doses of the Tai Chi intervention. 60 patients (30 per dose arm) will be randomized to a "low dose" of Tai Chi (the dose used in our previous studies with heart failure patients) or to a "high dose" matching current recommendations for the frequency and duration of exercise classes in current CRPs. We will obtain estimates of the effect of each dose on physical activity and on the proportion of patients achieving current recommendation for physical activity. Additional outcomes will be body weight, fitness, quality of life, exercise self-efficacy, mindfulness, perceived social suppor, depression and sleep. Measurements will be conducted at baseline, 3-, 6-, and 9- months after enrollment. Lastly, (aim 3) the investigative team will make the final adjustments to the Tai Chi intervention protocol based on findings from the dosing study and will finalize the design of the future RCT.

描述（由申请人提供）：心脏康复计划（CRP）可降低从急性冠状动脉事件或血运重建手术中恢复的患者的总体死亡率和心血管死亡率。 CRP 后，可改变的冠状动脉危险因素（例如身体缺乏活动、超重和高血脂水平）也会得到改善。然而，目前只有 30% 的患者参加 CRP，流失率可能达到 60%。障碍包括年龄较大、女性、对 CRP 中提出的运动训练类型的恐惧或不喜欢、缺乏社会支持、抑郁以及距 CRP 中心的距离。显然，需要针对那些未参加目前可用课程的人的特点和需求制定适合的课程。太极拳是一种基于轻/中度有氧运动并伴有冥想成分的身心干预方法，可以改善久坐的老年人的有氧能力，以及心力衰竭患者的运动自我效能、生活质量和情绪。老年人和身体虚弱的人可以安全地练习太极拳；它不需要任何特殊设备，可以在任何时间和地点进行。由于太极拳通常以团体形式教授，即使对于高危患者也是安全的，因此它已成功在社区中心提供，从而克服了交通障碍并限制了成本。所有这些特征表明，太极拳可以克服传统 CRP 的多重障碍，并且可以作为不愿意参加传统 CRP 的患者的替代干预措施。我们的长期目标 正在进行一项 III 期随机临床试验 (RCT)，以确定太极拳在改善最近发生冠状动脉事件或无法或不愿意参加传统 CRP 的患者的整体身体活动方面的功效。这项治疗开发研究的目的是确定太极拳干预这一新人群的内容、最佳剂量、可行性和安全性，并优化未来随机对照试验的设计。具体来说，（目标 1）我们将使用改进的德尔菲技术来开发太极干预，以满足近期发生冠状动脉事件或无法或不愿意参加传统 CRP 的患者的特定康复需求。接下来，（目标 2）我们将通过比较两种剂量太极拳干预的可行性、可接受性和安全性来确定适当的干预剂量。 60 名患者（每个剂量组 30 名）将被随机分配接受“低剂量”太极拳（我们之前对心力衰竭患者的研究中使用的剂量）或“高剂量”，该剂量与当前 CRP 中运动课程频率和持续时间的建议相匹配。我们将获得每种剂量对身体活动的影响以及达到当前建议的身体活动的患者比例的估计值。其他结果包括体重、健康、生活质量、运动自我效能、正念、感知的社会支持、抑郁和睡眠。测量将在基线、入组后 3、6 和 9 个月进行。最后，（目标3）研究团队将根据剂量研究的结果对太极干预方案进行最终调整，并最终确定未来随机对照试验的设计。